Labeled implantable medical devices

ABSTRACT

In general, techniques are described for labeling an implantable medical device (IMD). In one example, an IMD can include a housing including electronic circuitry. The IMD can include a header coupled to the housing and includes a core. The core can define a bore and include a first metal label positioned adjacent to the at least one bore. The IMD includes a lead assembly including at least one lead having a distal end and a proximal end, the at least one lead including a second metal label, the distal end including at least one electrode and the proximal end received within the bore.

CLAIM OF PRIORITY

This application is a continuation of U.S. application Ser. No.14/492,863, filed Sep. 22, 2014, which claims the benefit of priorityunder 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No.61/883,237, filed on Sep. 27, 2013, which is herein incorporated byreference in its entirety.

TECHNICAL FIELD

This document relates generally to medical devices and, in particular,to labels for implantable medical devices.

BACKGROUND

Implantable medical devices (IMDs) can perform a variety of diagnosticor therapeutic functions. In an example, an IMD can include one or morecardiac function management features, such as to monitor the heart or toprovide electrical stimulation to a heart or to the nervous system. Thecardiac function management features can be used to diagnose or treat asubject, for example, in cases of electrical or mechanical abnormalitiesof the heart. Examples of IMDs can include pacers, automatic implantablecardioverter-defibrillators (ICDs), cardiac resynchronization therapy(CRT) devices, implantable monitors, neuromodulation devices (e.g., deepbrain stimulators, or other neural stimulators), cochlear implants, ordrug pumps, among other examples.

Such IMDs can include a housing carrying electronic circuitry configuredto wirelessly transfer information between implanted IMDs, or between anIMD and an assembly external to the body. Such information can include,for example, programming instructions or configuration information toconfigure the IMD to monitor, diagnose, or treat a physiologiccondition. Such information can also include data sensed, detected, orprocessed by the IMD and transmitted to another device or assembly(e.g., physiologic information, a disease status, etc.). Electrodes canbe connected to the housing via a connective part referred to as aheader. The header and the leads have largely been standardized. Theheader can include a relatively deep female socket (e.g., a bore) havinga number of contact surfaces whereas the lead can be provided with amale part comprising one or several corresponding peripheral, generallycircular contact surfaces. Each lead has a designated bore, andinserting a lead into an incorrect bore of the header can causemalfunctions of the IMD after implantation.

The leads are electrically connected to the electronic circuitry of thehousing via one or more contact wires extending from the housing. Thenumber of contact wires can vary and as the number of contact wireincreases, the risk of wire crossing can also increase. Incorrectconnection of leads into the bores and wire crossing can cause variouserrors such as the stimulation or sensing of the wrong chambers of theheart, incomplete or intermittent connectivity between leads and theIMD, or ineffective defibrillation therapy. Correcting the errors canresult in extended procedure durations. In some cases, correcting theerrors can require subsequent surgical revisions, thereby increasing thepatient's risk of morbidity and mortality.

Overview

Generally, implantable medical devices (IMDs) can include a pacemaker, adefibrillator, a cardiac resynchronization therapy device, aneurostimulation device, an implantable monitoring device, or one ormore other devices. An IMD may generate an electrostimulation to bedelivered to a desired tissue site. Delivery of the electrostimulationmay be via electrodes that may be included as a portion of animplantable lead assembly. The lead assembly may be mechanically andelectrically coupled to the IMD to interface with circuitry included inthe IMD.

The present inventors have recognized among other things that aproliferation of lead or electrode configurations may complicatecoupling the leads to the IMD and complicate the coupling of theelectronic circuitry contained within the housing to the leads. Forexample, each lead is coupled to the IMD such that the lead iselectrically coupled to accompanying circuitry contained in the housing.In order to reduce the risk of incorrectly coupling a lead to the headerand incorrectly coupling the circuitry, the present inventors haveprovided a labeling system and method that is low cost andbiocompatible.

Previous approaches have incorporated inks to label various componentsof IMDs. However, in order to incorporate ink for use with IMDs, theinks go through stringent biocompatibility testing. The complexity ofink and pigment systems can increase the cost of biocompatibilityverification and product validation. The continuous monitoring of inkand pigment purity can increase the cost of providing a labeling systemfor IMDs.

Various embodiments of the present disclosure can provide abiocompatible color coded and text labeling system for IMDs. Forexample, biocompatible metals can be anodized to color the surfacewithout altering the biocompatibility of the material. Anodizing thebiocompatible metals does not compromise the integrity and properties ofthe biocompatible metal and maintains the suitability of thebiocompatible metal for use in biomedical applications. In an example,the biocompatible metals can be anodized to provide text to the surfaceto assist in labeling components of the IMDs. Imparting color and textto various components of the IMDs can assist in identification of partsand reduce the risk of incorrectly manufacturing, assembling, andimplanting the IMDs. The benefits of this are advantageous in surgicalapplications and in the assembly of complex IMDs.

The present disclosure can provide labeling to IMDs by includingbiocompatible metal substrates that have been anodized to provide anidentifier including at least one of color and text. The anodizedbiocompatible metal substrates are biocompatible and can reduce the riskof incorrect assembly such as wire crossing and incorrectly couplingleads. The labels and methods described herein can eliminate an unstablecomponent (e.g., ink) and eliminate the biocompatibility risk of usingother labeling methods. Additionally, the IMDs and methods describedherein have flexible manufacturing and a low cost of implementation.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents.

The drawings illustrate generally, by way of example, but not by way oflimitation, the various examples discussed in the present document.

FIG. 1 illustrates generally an example of a system including an IMD.

FIG. 2 illustrates generally a close-up of a portion of the example ofthe IMD of FIG. 1.

FIG. 3A is a perspective view of the example of a core of the IMD ofFIG. 2.

FIG. 3B is a side view of the example of the core in FIG. 3A.

FIG. 4 is a perspective view of an example of a header including thecore in FIG. 3A.

FIG. 5A is a perspective view of an example of a core of the IMD of FIG.2.

FIG. 5B is a side view of the example of the core in FIG. 5A.

FIG. 6 is a perspective view of an example of a lead assembly of the IMD12.

FIG. 7 is a perspective view of an example of a header and housing ofthe IMD 12.

FIG. 8 illustrates generally an example of a method of labeling animplantable medical device.

FIG. 9 illustrates generally an example of a method of labeling animplantable medical device.

DETAILED DESCRIPTION

FIG. 1 illustrates generally an example of a system 10 that can includean implantable medical device (IMD) 12 implanted within a body (e.g., apatient 14), wirelessly coupled to an external module 16. In an example,the IMD 12 can include an implantable device housing 18 including aconductive portion (e.g., a hermetically-sealed titanium housing, or ahousing including one or more other materials), a header 22, and one ormore implantable lead assemblies 24. The header 22 can mechanically andelectrically couple the one or more implantable lead assemblies 24 tothe housing 18 and electrical circuitry contained in the housing 18.

In an example, the IMD 12 may be coupled to one or more implantable leadassemblies, such as one or more intravascularly-deliverable leadassemblies 24. The one or more lead assemblies 24 may be configured toprovide electrostimulation to one or more sites on, within, or near aheart 26. For example, such lead assemblies 24 may include multipleleads 27A, 27B, and 27C (collectively referred to as “leads 27”). Theleads 27 can include one or more electrodes.

For example, lead 27A may include electrode 28 associated with rightventricle 36, such as tip electrode and/or a ring electrode. Theelectrode 28 is “associated” with the particular heart chamber byinserting it into that heart chamber, by inserting it into a portion ofthe heart's vasculature that is close to that heart chamber, byepicardially placing the electrode outside that heart chamber, or by anyother technique of configuring and situating an electrode for sensingsignals and/or providing therapy with respect to the heart chamber. Lead27B can include electrode 30 associated with the right atrium 32, suchas tip electrode and/or ring electrode. Lead 27C, which can beintroduced into the coronary sinus and/or the great cardiac vein or oneof its tributaries, can include electrode 29 associated with leftventricle 34, such as tip electrode and/or ring electrode. While theexample in FIG. 1 includes three leads configured to be positionedwithin the heart, the number and location of the leads can varydepending on the type of therapy to be provided and the type of IMD.

In an example, the IMD 12 may include one or more electrodes located onthe housing 18 of the IMD 12, such as housing electrode 38 and/or headerelectrode 42, which are useful for, among other things, unipolar sensingof heart signals or unipolar delivery of contraction-evokingstimulations in conjunction with one or more of the electrodes 28, 29,and 30 associated with heart 26.

The housing 18 can contain at least a portion of an implantablecircuitry 20, such as a transmitter, a receiver, or a transceiver. In anexample, the IMD 12 can include a header 22 that is configured tomechanically and electrically couple the one or more lead assemblies 24to the implantable circuitry 20 of the housing 18. The IMD 12 caninclude an antenna within the header 22 configured to wirelesslytransfer information electromagnetically to an external module 16. In anexample, the external module 16 can include an external antenna coupledto an external telemetry circuit.

In an example, the external module 16 can include a physicianprogrammer, a bedside monitor, or other relatively nearby assembly usedto transfer programming instructions or configuration information to theIMD 12, or to receive diagnostic information, a disease status,information about one or more physiologic parameters, or the like, fromthe IMD 12. The external module 16 can be communicatively connected toone or more other external assemblies, such as a remote externalassembly, located elsewhere (e.g., a server, a client terminal such as aweb-connected personal computer, a cellular base-station, or anotherwirelessly-coupled or wired remote assembly).

As discussed herein, the proliferation of lead and electrodeconfigurations can complicate coupling the leads 27 to the housing 18via the header 22. In the example of FIG. 1, the header 22 can includeheader labels 40A-C (collectively referred to herein as “header labels40”) and the leads 27 can include lead labels 41A-C (collectivelyreferred to herein as “lead labels 41”). The header and lead labels 40and 41 can be made from a biocompatible material such as a biocompatiblemetal substrate. For example, the header and lead labels 40, 41 can beformed from titanium, tantalum, tungsten, stainless steels, Nitinol,cobalt-chrome alloys, palladium, platinum, and other noble metals. Thebiocompatible metal substrate can be anodized to include an identifier.The identifier can include at least one of color and text. The headerand lead labels 40 and 41 that include the identifier (e.g., at leastone of color and text) can assist in the manufacture, assembly, andimplanting of the IMD 12.

FIG. 2 illustrates generally an example of the IMD 12 of FIG. 1. The IMD12 includes the housing 18, the header 22, and the lead assembly 24. Inan example, the header 22 can include a core 48 positioned within aheader housing 46. The header housing 46 and core 48 can define bores50A-C (collectively referred to as “bores 50”). As illustrated in FIG.2, each lead 27A-C is positioned within a respective bore 50A-C. Forexample, lead 27A is positioned in bore 50A, lead 27B is positioned inbore 50B, and lead 27C is positioned in bore 50C. The header labels 40and the lead labels 41 can provide a visual aide to reduce the risk ofincorrectly coupling the leads 27 to the header 22.

In an example, core 48 can be formed from a dielectric material such aspolyurethane, polyether ether ketone, epoxy, and other materials. In anexample, the header housing 46 can be translucent and formed form adielectric material. The header housing 26 can be translucent such thatthe header labels 40 are visible through the header housing 46.

In an example, each of the header labels 40A-C can be anodized toprovide an anodized metal label that includes an identifier. Anodizingcan include growing an oxide layer on a surface, which can generate arange of different colors. A further explanation of anodizing isprovided herein. Each identifier of the header labels 40A-C cansubstantially match an identifier of a respective header label of theheader labels 40. Each header label 40A-C can be positioned adjacent toa respective bore of bores 50A-C to visually indicate a relationshipwith the particular bore. In an example, the header label 40A can beassociated with the bore 50A. The header label 40A is associated withthe bore 50A by being positioned on the core 48 at a location adjacentto the bore 50A to indicate the relationship. In an example, the headerlabel 40B can be associated with the bore 50B and the header label 40Ccan be associated with the bore 50C.

As illustrated in the example of FIG. 2, the lead 27A, configured toconnect to the housing 18 via the bore 50A, can include the lead label40A having an identifier that substantially matches the identifier ofthe header label 40A, thereby indicating that the lead 27A is correctlycoupled to the housing 18 via bore 50A. In an example, the identifierfor the header label 40A and lead label 41A can be a color. That is, thesurface of the header label 40A and the surface of the lead label 41Acan be anodized to provide color 51. In an example, color 51 can be red.Therefore, an operator can easily and visually understand that the lead27A (e.g., having color 51) connects to the housing 18 via bore 50A(e.g., having color 51) of the core 48.

In an example, the header label 40B can be associated with the bore 50B.Lead 27B can be configured to connect to the housing 18 via the bore50B. The header label 40B and the lead label 41B can include the sameidentifier. For example, the surface of the header label 40B and thesurface of the lead label 41B can be anodized to provide color 52. In anexample, color 52 is different from color 51. In an example, color 51can be red and color 52 can be blue. Therefore, an operator can easilyand visually understand that the lead 27B (e.g., having color 52)connects to the housing 18 via bore 50B (e.g., having color 52).

In an example, the header label 40C can be associated with the bore 50C.Lead 27C can be configured to connect to the housing 18 via the bore50C. The header label 40C and the lead label 41C can include the sameidentifier. For example, the surface of the header label 40 C and thesurface of the lead label 41C can be anodized to provide color 53. In anexample, color 53 is different from color 51 and color 52. For example,color 51 can be red, color 52 can be blue, and color 53 can be yellow.Therefore, an operator can easily and visually understand that the lead27C (e.g., having color 53) connects to the housing 18 via bore 50C(e.g., having color 53).

Various biocompatible metals can be used to provide the header labels 40and the lead labels 41. As discussed herein, anodizing biocompatiblemetals can provide a range of colors. For example, biocompatible metalscan be anodized to provide colors including, but not limited to, black,grey, brown, purple, blue, yellow, red, orange, and green.

In an example, the header labels 40 can be anodized to provide text thatcan further help reduce the risk of incorrect assembly, manufacture, andimplanting the IMD 12. The text can be provided to header labels 40after the header labels 40 have been anodized to include a color (e.g.,a background color). As illustrated in the example of FIG. 2, headerlabel 40A can be anodized to provide text such as “RV” 43. As discussedin FIG. 1, lead 27A can be configured to be associated with the rightventricle of the heart 26. Thus, the text “RV” 43 can assist a surgeonwhile implanting the IMD 12. The text “RV” 43 can be black to contrastwith the color 51 of the header label 40A. Header label 40B can includetext “RA” 44 indicating the lead 27B is configured to be inserted intothe right atrium. Further, header label 40C can include text “LV”indicating the lead 27C is configured to be inserted into the leftventricle. In an example, the lead labels 41A-C can also be modified toinclude the text. In an example, the text can include letters, numbers,symbols, and/or other graphics.

Anodizing the biocompatible metal substrates to provide color and textcan be done by at least one of an electrochemical anodizing process anda LASER anodizing process. In an example, the color can be provided byusing the electrochemical anodizing process and the text can be providedby using the LASER anodizing process. The electrochemical anodizingprocess can include electrochemically growing an oxide layer on thesurface of the biocompatible metal substrate to form the header and leadlabels 40, 41 including a first identifier (e.g., color). For example,voltage can be applied to an electrolytic bath including the componentto include the color. The voltage applied can control the thickness ofthe oxide layer, which determines the color produced on the component.

The LASER anodizing process can include growing oxide layers on thesurface of the biocompatible metal substrate via a laser treatment. Forexample, oxide layers are grown to precise thicknesses based on laserheating in an oxygen bearing atmosphere. In an example, either theelectrochemical or the LASER anodizing process can be used to providethe color. In an example, the electrochemical anodizing process can beused to provide the color and the LASER anodizing process can be used toprovide the text.

In the example of FIG. 2, the header labels 40A-C have a square shape.However, the shapes of the header labels 40A-C can include other shapes.For example, the shapes of the header labels 40A-C can be modified to bedifferent from each other to further distinguish the header labels 40A-Cfrom each other. In an example, header label 40A can be a square, headerlabel 40B can be a triangle, and header label 40C can be a circle.

FIG. 3A is a perspective view of an example of the core 48 of the IMD 12of FIG. 2. The core 48 can include a superior surface 54, an inferiorsurface 56, and two side wall surfaces 64, 66. A first face 60 and asecond face 62 can extend between the superior surface 54, the inferiorsurface 56, and the two side wall surfaces 64, 66. The core 48 caninclude the bores 50A-C extending from the first side wall surface 64toward the second side wall surface 66. The core 48 can include aplurality of connector block openings 68 configured to receive connectorblocks (as shown as connector blocks 104A-B, 106A-D, and 108 in FIG. 7).The connector block openings 68 can extend from the first face 60 to thesecond face 62 of the core 48. In another example, one or more of theplurality of connector block openings 68 extend partially into the core48. The connector block openings 68 can be in communication with thebores 50A-C such that the connector blocks, when inserted into theconnector block openings 68, interface with contact surfaces of theleads 27A-C.

In the example of FIG. 3A, the core 48 includes receiving cavities 70A-Calong the first side wall 64 of the core 38. The receiving cavities70A-C can be slots that extend into the first side wall 64 of the core48 and are configured to receive the header labels 40A-C. For example,the header labels 40A-C can be metal substrates that are sized andshaped to be inserted into the receiving cavities 70A-C. The core 48 caninclude windows 72A-C that are in communication with the receivingcavities 70A-C. For example, when the header labels 40A-C are insertedinto the receiving cavities 70A-C, a portion of the surface of theheader labels 40A-C is visible through the windows 72A-C. The receivingcavities 70A-C can have a larger area than the windows 72A-C to provideinitial stability when the metal substrates (e.g., pre-anodized orblank) are inserted into the receiving cavities 70A-C. As discussedherein, the header labels 40A-C can be anodized prior to being insertedinto the receiving cavities 70A-C or after being inserted into thereceiving cavities 70A-C. In one example, the header labels 40A-C can beanodized prior to being inserted into the receiving cavities 70A-C, andthe text (as discussed herein with FIG. 2) can be provided to the headerlabels 40A-C after the header labels 40A-C are inserted into thereceiving cavities 70A-C.

FIG. 3B is a side view of the example of the core 48 in FIG. 3A. In theexample shown in FIG. 3B, the receiving cavities 70A-C are positionedadjacent to the bores 50A-C. For example, receiving cavity 70A ispositioned adjacent to bore 50A, receiving cavity 70B is positionedadjacent to bore 50B, and receiving cavity 70C is positioned adjacent tobore 50C. In other words, receiving cavity 70A is positioned closer tobore 50A than bore 50B or 50C, receiving cavity 70B is positioned closerto bore 50B than bore 50A or 50C, and receiving cavity 70C is positionedcloser to bore 50C than bore 50A or 50B.

FIG. 4 is a perspective view of an example of a header 22 of the IMD 12.The header 22 can include the core 48 (as shown in FIGS. 3A and 3B) andthe header housing 46. The header housing 46 can be overmolded over thecore 48. The header housing 46 and the core 48 can define the bores50A-C that can be configured to receive the leads 27A-C (shown in FIGS.1 and 2). In the example of FIG. 4, the header labels 40A-C arepositioned within the receiving cavities (shown as 70A-C in FIG. 3B). Inan example, the header labels 40A-C are square metal substrates thathave a surface area greater than the area of the windows 72A-C.Providing the header labels 40A-C with a surface area greater than thewindows 72A-C can allow for the header labels 40A-C to be securelypositioned within the core prior to anodizing (e.g., for color and/ortext) and/or overmolding.

In one example, the header labels 40A-C can be inserted into thereceiving cavities 70A-C as blank metal substrates and can be anodized(e.g., to include color and text) after being inserted into the core 48.In another example, the header labels 40A-C can be anodized (e.g., toinclude color and text) prior being inserted into the receiving cavities70A-C.

In an example, the header labels 40A-C can be anodized to provide afirst identifier (e.g., color) prior to being inserted into thereceiving cavities 70A-C and can be anodized to provide a secondidentifier (e.g., text) after being inserted into the receiving cavities70A-C. For example, header label 40A can be anodized to include color51, header label 40B can be anodized to include color 52, and headerlabel 40C can be anodized to include color 53. After the color is addedto each of the header labels 40A-C, the header labels 40A-C can beinserted into the receiving cavities 70A-C. In an example where text isto be provided, the text can be provided to the header labels 40A-Cafter the header labels 40A-C have been inserted into the receivingcavities 70A-C. For example, the header labels 40A-C can be anodized toinclude the text. For example, the text “RA”, “LV” and “RV” can beprovided to header labels 40A-C after the header labels 40A-C have beeninserted into the receiving cavities 70A-C. In that way, the text can besure to be visible through the windows 72A-C. In an example, the firstidentifier (e.g., color) is added to the header labels 40A-C prior tothe second identifier (e.g., text).

In an example, the header labels 40A-C can have a size that is greaterthan the windows 72A-C and the header labels 40A-C are inserted into thereceiving cavities. In an example, the windows 72A-C can be thereceiving cavities and the header labels 40A-C can be placed into thewindows 72A-C. For example, the header labels 40A-C can havesubstantially the same as the windows 72A-C such that the header labels40A-C can be placed into the windows 72A-C acting as the receivingcavity. In another example, the core 48 does not include receivingcavities and the header labels 40A-C are coupled to the first face 60 ofthe core 48, for example, via a biocompatible adhesive.

FIG. 5A is a perspective view of an example of the core 48 of the IMD ofFIG. 2. While the header labels 40A-C in FIG. 4 are illustrated asseparate independent labels, FIG. 5A illustrates an example of a core 48including a single header label 74. For example, the core 48 can includea single receiving cavity 76 (as shown in FIG. 5B) along the first sidewall 64. The header label 74 can be inserted into the receiving cavity76 such that portions of the header label 74 can be seen through thewindows 72A-C. The header label 74 can be selectively anodized such thata portion 78 of the header label 74 adjacent to the bore 50A has thecolor 51, a portion 80 of the header label 74 adjacent to the bore 50Bhas the color 52, and a portion 82 of the header label 74 adjacent tothe bore 50C has the color 53. In an example, the portions 78, 80, and82 can also be anodized to include text. For example, portion 78 caninclude text “RV,” portion 80 can include text “RA,” and portion 82 caninclude text “LV.”

FIG. 6 is a perspective view of an example of a lead assembly 24 of theIMD 12. As discussed herein, the IMD 12 can include one or more leadassemblies such as lead assembly 24. The lead assembly 24 can includethe leads 27A-C. The leads 27A-C can include a distal end 84 and aproximal end 86. The distal end 84 can include electrodes configured toprovide therapy to adjacent tissue. For example, lead 27A can includeelectrode 29, lead 27B can include electrode 30, and lead 27C caninclude lead 29. In an example, the proximal end 86 can include leadlabels 41A-C, as discussed herein.

The lead labels 41A-C can be formed from biocompatible materials. Forexample, the lead labels 41A-C can be formed from biocompatible metalssuch as titanium, tantalum, tungsten, stainless steels, Nitinol,cobalt-chrome alloys, palladium, platinum, and other noble metals. Eachof lead labels 41A-C can include an identifier. For example, theidentifier can include at least one of a color and text. In the exampleof FIG. 4, lead label 41A can be anodized to have the color 51, leadlabel 41B can be anodized to have the color 52, and lead label 41C canbe anodized to have the color 53.

In an example, the lead labels 41A-C can be annular rings that arepositioned around an exterior surface 100 of leads 27A-C. In an example,the lead labels 41A-C can have an interference fit with the leads 27A-C.For example, the lead labels can be crimped onto the leads 27A-C. Theportion of the leads 27A-C that include the lead labels 41A-C positionedaround the exterior surface can be overmolded with a transparentpolymeric material to provide a smooth exterior surface 100, whileallowing the identifier (e.g., color or text) to be visible.

In an example, the lead labels 41A-C can be integrated into a body ofthe leads 27A-C. For example, annular metal rings can be anodized andcan be molded into the body of the leads with transparent polymericmaterials.

The proximal end 86 of leads 27A-C can include a proximal portion 88A-Cthat is configured to be received within the bores 50A-C of header 22(as shown in FIG. 2). The proximal portions 88A-C can include contactsurfaces configured to contact connector blocks within the core, asdiscussed herein, and a tip. For example, lead 27A can include portion88A that is configured to be received within bore 50A (shown in FIG. 2).Portion 88A can include a tip contact 94 and contact rings 90A and 90B.Lead 27B can include portion 88B that is configured to be receivedwithin bore 50B (shown in FIG. 2). Portion 88B can include a tip contact96 and contact rings 91A and 91B. Lead 27C can include portion 88C thatis configured to be received within bore 50C (shown in FIG. 2). Portion88C can include a tip contact 98 and contact rings 92A and 92B. Whileportions 88A-C each include two contact rings and one tip contact, otherconfigurations are possible. For example, each portions 88A-C caninclude one to three ring contacts and one tip contact.

The tip contacts 94, 96, and 98 and the contact rings 90A, 90B, 91A,91B, 92A, and 92B can be formed from biocompatible materials asdiscussed herein. In some examples, the tip contacts 94, 96, and 98and/or one or more of the contact rings 90A, 90B, 91A, 91B, 92A, and 92Bcan be anodized to provide the identifier. In an example, the tipcontacts can be anodized to provide the identifier. That is the tips 94,96, and 98 and/or one or more of the contact rings 90A, 90B, 91A, 91B,92A, and 92B can be the lead labels for the leads 27A-C. For example,the tip contact 94 and/or one or more of contact rings 90A and 90B canbe anodized to provide the color 51, the tip contact 96 and/or one ormore of contact surfaces 91A and 91B can be anodized to provide thecolor 52, and tip contact 98 and/or one or more contact surfaces 92A and92B can be anodized to provide the color 53.

FIG. 7 is a perspective view of an example of a header 22 and a housing18 of the IMD 12. As discussed herein, header 22 can include a core 48positioned within the header housing 46, where the header housing 46 andthe core 48 define bores 50A-C. In the example of FIG. 7, the header 22can include an antenna 110 positioned along a portion of the core 48 andat least partially within the header housing 46.

The header 22 in FIG. 7 includes connector blocks 104A-B, 106A-D, and108 positioned within the connector block openings 68. Connector blocks104A-B, 106A-D, and 108 can electrically and mechanically mate with oneor more of the leads 27A-C. For example, the connector blocks 104A-B,106A-D, and 108 can provide contact surfaces that can interact with thecontact rings 90A, 90B, 91A, 91B, 92A, and 92B and tip contacts 94, 96,and 98 of the leads 27A-C (as shown in FIG. 6) when the leads 27A-C arepositioned within the bores 50A-C.

In an example, a plurality of contact wires 112, 113, 114, 115, 116,117, 118, and 119 can extend from a top portion 120 of the housing 18.The contact wires 112, 113, 114, 115, 116, 117, 118, and 119 can couplewith the connector blocks 104A-B, 106A-D, and 108 to electrically couplethe leads 27A-C to the electrical circuitry 20 contained within thehousing 18. While the example of FIG. 7 includes eight contact wires,the number of contact wires can depend on the type of IMD 12 and thetherapy to be provided. In one example, the number of contact wires canvary between 2 wires to 32 wires. In an example, the number of contactwire can be greater than 32 wires. However, as the number of contactwires increases, the risk of incorrectly connecting wires (e.g., wirecrossing) can also increase.

In an example, one or more of the contact wires 112, 113, 114, 115, 116,117, 118, and 119 can be anodized to include an identifier such as acolor. For example, contact wires 115 and 117 are configured to coupleto connector blocks 104A and 104B associated with bore 50A. Thus,contact wires 115 and 117 can be anodized to include an identifier suchas the color 51 (e.g., red). Thus, an operator can easily and visuallyconfirm that contact wires 115 and 117 (having color 51) are to becoupled to the connector blocks 104A-B associated with bore 50A (havingheader label 40A including color 51).

In an example, contact wires 114, 116, 118, and 119 can be anodized toinclude an identifier such as the color 52 (e.g., blue). Thus, anoperator can easily and visually confirm that contact wires 114, 116,118, and 119 (having color 52) are to be coupled to the connector blocks106A-D associated with bore 50BA (having header label 40B includingcolor 52). Further, contact wire 113 can be anodized to include anidentifier such as the color 53 (e.g., yellow). Thus, an operator caneasily and visually confirm that contact wire 113 (having color 53) isto be coupled to the connector block 108 associated with bore 50C(having header label 40C including color 53). The contact wire 112 maynot be anodized and have a color of a pre-anodized biocompatible metal(e.g., silver).

In an example, connector blocks 104A-B, 106A-D, and 108 can also beanodized to include the identifier (e.g., color) to further assist theoperator or surgeon. For example, connector blocks 104A-B can beanodized to have color 51, connector blocks 106A-D can be anodized tohave color 52, and connector block 108 can be anodized to include color53. The connector blocks can be anodized in addition to or in lieu ofthe header labels 40A-C. In one example, the header labels 40A-C canonly include the text “RV”, “RA”, and LV”, respectively, while theconnector blocks can include colors 51, 52, and 52, respectively.

FIG. 8 is an example of a method 200 of labeling an IMD. In describingthe method 200 reference is made to features and elements previouslydescribed herein, including numbered references. Numbered elementsprovided within the description of the method 200 are not intended to belimiting, instead numbered references are provided for convenience andcan include any similar features described herein, as well as theirequivalents.

The method 200, at 202, can include coupling a first biocompatible metalsubstrate and a second biocompatible metal substrate to a core of aheader of the implantable medical device. For example, a firstbiocompatible metal substrate and a second biocompatible metal substratecan be coupled to a core 48 of a header 22 of the IMD 12. The core 48can have a first bore 50A and a second bore 50B, where the firstbiocompatible metal substrate is positioned adjacent to the first bore50A and the second biocompatible metal substrate is positioned adjacentto the second bore 50B. For example, the metal substrates can be theheader labels 40A and 40B, as shown in FIG. 4. Coupling thebiocompatible metal substrates can be done as described herein withreference to FIGS. 3A and 3B. For example, the biocompatible metalsubstrates (e.g., header labels 40A and 40B) can be inserted intoreceiving cavities 70A and 70B.

The method 200 can include forming the core 48 to include a firstreceiving cavity (e.g., receiving cavity 70A) and a second receivingcavity (e.g. receiving cavity 70B). The first receiving cavity 70A canbe configured to receive the first biocompatible metal substrate (e.g.,header label 40A) and the second receiving cavity can be configured toreceive the second biocompatible metal substrate (e.g., header label40B).

Method 200, at 204, can include anodizing the first biocompatible metalsubstrate to include at least a first color and, at 206, method 200 caninclude anodizing the second biocompatible metal substrate to include atleast a second color. As discussed herein, the first color and secondcolor are different from each other. In one example, the electrochemicalanodizing process can be used. In another example, the first and secondcolor can be provided using the LASER anodizing process.

The method 200 can include anodizing the first biocompatible metalsubstrate to include a first text and anodizing the second biocompatiblemetal substrate to include a second text, where the second text isdifferent from the first text. For example, as shown in FIG. 4, theheader label 40A can be anodized to include the text “RV.” In oneexample, the LASER anodizing process can be used to provide the text. Inan example, the text can be provided in a color such as black thereby tocontrast with the first and second colors provided to the first andsecond biocompatible metal substrates, respectively.

Anodizing can generate an array of different colors without using dyesor inks. The anodizing process provides an oxidized surface withcontrolled thicknesses on the scale of visible light wavelengths. Thecolor formed is dependent on the thickness of the oxide layer, which isdetermined by a variety of process factors. During the electrochemicalanodizing process, voltage is applied to an electrolytic bath includingthe component to include the color. The voltage applied can control thethickness of the oxide layer and thereby control the color produced onthe component. During the LASER anodizing process, a laser beam ispassed over the surface of the metal substrate. The pulse rate, power(e.g., voltage), focal point size, rate traveled, and pass rate of thelaser, component mass, thermal conductivity, process atmosphere, thermalfixtures, focal depth, and angles of incidence can affect the thicknessof the oxide layer and thereby control the color produced on thecomponent.

The method 200 can include texturing the surface of the biocompatiblemetal substrates prior to or after anodizing the biocompatible metalsubstrates. The textured surface can minimize refraction such that anaverage color is represented to the viewer. The textured surface canprovide a more constant and accurate color that is not dependent on aviewing angle. In one example, the biocompatible material, prior to orafter anodizing, can be sent through a press having protrusions toprovide a textured surface. In another example, the laser beam used toprovide the anodizing can be utilized to texture the surface.

As discussed herein, the method 200 can include anodizing the firstbiocompatible metal substrate and anodizing the second biocompatiblemetal substrate prior to coupling the first biocompatible metalsubstrate and the second biocompatible metal substrate to the core.Alternatively, the method 200 can include anodizing the firstbiocompatible metal and anodizing the second biocompatible metalsubstrate after coupling the first biocompatible metal substrate and thesecond biocompatible metal substrate to the core.

In one example, the biocompatible metal substrates are anodized usingthe electrochemical anodizing process to provide the color. The anodizedbiocompatible metal substrates can then be coupled to core of theheader. Once coupled to the core, the biocompatible metal substrates canbe anodized using the LASER anodizing process to provide the text.

The method 200, at 208, can include overmolding the core including thefirst biocompatible metal substrate and the second biocompatible metalsubstrate. For example, core 48 including the biocompatible metalsubstrates (e.g., header labels 40A-40C) can be overmolded to form theheader housing 46 of the header 22. That is the header housing 46 can beovermolded or otherwise formed around the core 48.

The method 200 can include coupling a first lead of a lead assembly tothe first bore and coupling a second lead of a lead assembly to thesecond bore. For example, lead 27A of lead assembly 24 can be coupled tobore 50A and lead 27B of lead assembly 24 can be coupled to bore 50B.

The method 200 can include anodizing a first annular ring to include thefirst color and anodizing a second annular ring to include the secondcolor. For example, the first annular ring 41A can be anodized to form acolor (e.g., color 51), which is the same as the color 51 of the headerlabel 40A. Additionally, the second annular ring 41B can be anodized toform a color (e.g., color 52), which is the same as the color 52 of theheader label 40B. The method 200 can include coupling the first annularring to a proximal end of the first lead 27A and coupling the secondannular ring 41B to a proximal end of the second lead 27B. For example,the annular rings 41A-C can be coupled to the leads 27A-C by aninterference fit and crimping. Additionally, the annular rings 41A-C canbe positioned within a circumferential groove of the leads 27A-C. In anexample, the lead labels 41A-C can be integrated into a body of theleads 27A-C. For example, annular metal rings (e.g., lead labels 41A-C)can be anodized and can be molded into the body of the leads 27A-C withtransparent polymeric materials.

The method 200 can include anodizing a first contact wire extending froma housing including electronic circuitry to include the first color andanodizing a second contact wire extending from the housing to includethe second color. As described herein with respect to the example ofFIG. 7, contact wires 112-119 can be anodized to include a color. Thecolor of each of the contact wires 112-119 can assist a user inconnecting the contact wires 112-119 to the header 22. For example,contact wires 115 and 117 are configured to couple to connector blocks104A and 104B associated with bore 50A. Thus, contact wires 115 and 117can be anodized to include an identifier such as the color 51 (e.g.,red). Contact wires 114, 116, 118, and 119 can be anodized to include anidentifier such as the color 52 (e.g., blue). Further, contact wire 113can be anodized to include an identifier such as the color 53 (e.g.,yellow).

The method 200 can include coupling the first contact wire to theconnector block positioned within the first bore and coupling the secondcontact wire to a connector block positioned within the second bore. Forexample, contact wires 115 and 117 (e.g., having color 51) can becoupled to the connector blocks 104A-B associated with bore 50A (e.g.,having header label 40A including color 51), contact wires 114, 116,118, and 119 (e.g., having color 52) can be coupled to the connectorblocks 106A-D associated with bore 50BA (e.g., having header label 40Bincluding color 52), and contact wire 113 (e.g., having color 53) can becoupled to the connector block 108 associated with bore 50C (e.g.,having header label 40C including color 53).

FIG. 9 is an example of a method 300 of labeling an IMD. In describingthe method 300 reference is made to features and elements previouslydescribed herein, including numbered references. Numbered elementsprovided within the description of the method 300 are not intended to belimiting, instead numbered references are provided for convenience andcan include any similar features described herein, as well as theirequivalents.

The method 300, at 302, can include coupling a first biocompatible metalsubstrate to a core of a header of the implantable medical device. Forexample, a biocompatible metal substrate (e.g., header label 74) can becoupled to a core 48, as shown in FIG. 5A. The core 48 can have a firstbore 50A and a second bore 50B. Coupling the biocompatible metalsubstrate to the core can be done as described herein with reference toFIGS. 5A and 5B. For example, the biocompatible metal substrate (e.g.,header label 74) can be inserted into receiving cavity 76. Method 300can include forming the core 48 to include the receiving cavity 76,where the first receiving cavity 76 can be configured to receive thebiocompatible metal substrate (e.g., header label 76).

Method 300, at 304, can include anodizing a first portion of thebiocompatible metal substrate to include a first color, and at 306 caninclude anodizing a second portion of the biocompatible metal substrateto include a second color. For example, the header label 74 can beselectively anodized such that a portion 78 of the header label 74adjacent to the bore 50A has the color 51, a portion 80 of the headerlabel 74 adjacent to the bore 50B has the color 52, and a portion 82 ofthe header label 74 adjacent to the bore 50C has the color 53.

As discussed herein, the method 300 can include anodizing the firstportion of the biocompatible metal substrate and anodizing the secondportion of the biocompatible metal substrate prior to coupling thebiocompatible metal substrate to the core. In one example, the first andsecond portion of the biocompatible metal substrate can be anodizedusing the electrochemical anodizing process to provide the color.

Optionally, method 300, at 308, can include anodizing the first portionof the biocompatible metal substrate to include a first text, and at310, can include anodizing the second portion of the biocompatible metalsubstrate to include a second text. The method 300 can include anodizingthe first and second portion of the biocompatible metal substrate toinclude the first and second text, respectively, after coupling thebiocompatible metal substrate to the core. In one example, the first andsecond portion of the biocompatible metal substrate can be anodized toprovide text using the LASER anodizing process, as described herein.

The method 300, at 312, can include overmolding the core including thebiocompatible metal substrate. For example, core 48 including thebiocompatible metal substrate (e.g., header labels 74) can be overmoldedto form the header housing of the header 22. That is the header housingcan be overmolded or otherwise formed around the core 48, as describedherein.

Additional Notes and Examples

Example 1 can include subject matter that can include an implantablemedical device, comprising a housing including electronic circuitry, aheader coupled to the housing and including a core, the core defining abore and including a first metal label positioned adjacent to the atleast one bore, and a lead assembly including at least one lead having adistal end and a proximal end, the at least one lead including a secondmetal label, the distal end including at least one electrode and theproximal end received within the bore.

Example 2 can include, or can optionally be combined with the subjectmatter of Example 1, to optionally include where the first metal labeland the second metal label are chosen from at least one of titanium,tantalum, tungsten, and stainless steel.

Example 3 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1 or 2, to optionallyinclude where the first metal label includes a first identifier and thesecond metal label includes a second identifier, the first identifiersubstantially the same as the second identifier.

Example 4 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-3, to optionally includewhere the first identifier and the second identifier include at leastone of a color and text.

Example 5 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-4, to optionally includewhere the first identifier is a first color and the second identifier isa second color, the second color and the first color being substantiallythe same.

Example 6 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-5, to optionally includewhere the first metal label is an anodized metal substrate.

Example 7 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-6, to optionally includewhere a surface of the anodized metal substrate is textured

Example 8 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-7, to optionally includewhere a surface of the core defines a receiving cavity adjacent to thebore, the receiving cavity configured to receive the first metal label.

Example 9 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-8, to optionally includewhere the second metal label is an anodized metal annular ring.

Example 10 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-9, to optionally includewhere an exterior surface of the anodized metal annular ring istextured.

Example 11 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-10, to optionally includewhere an exterior surface of the lead defines a circumferential grooveconfigured to receive the second metal label.

Example 12 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-11, to optionally includewhere the core is overmolded with a dielectric material.

Example 13 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-12, to optionally includewhere at least a portion of the lead having the second metal isovermolded with a dielectric material.

Example 14 can include subject matter that can include an implantablemedical device, comprising a housing including electronic circuitry,wherein a first contact wire and a second contact wire extend from thehousing, the first contact wire including a first identifier and thesecond contact wire including a second identifier, a header coupled tothe housing, the header comprising a core defining a first bore and asecond bore, a first connector block in communication with the firstbore, a second connector block in communication with the second bore, afirst anodized metal label positioned adjacent to the first bore, and asecond anodized metal label positioned adjacent to the second bore, anda lead assembly including a first lead and a second lead, wherein thefirst lead is electrically coupled to the electronic circuitry via thefirst connector block and the second lead is electrically coupled to theelectronic circuitry via the second connector.

Example 15 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-14, to optionally includewhere the first contact wire is anodized to provide the firstidentifier, the first identifier being a first color.

Example 16 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-15, to optionally includewhere the second contact wire is anodized to provide the secondidentifier, the second identifier being a second color different fromthe first color.

Example 17 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-16, to optionally includewhere the first anodized metal label includes the first color.

Example 18 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-17, to optionally includewhere the second anodized metal label includes the second color.

Example 19 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-18, to optionally includewhere the first connector block has been anodized to include the firstcolor and the second connector block has been anodized to include thesecond color.

Example 20 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-19, to optionally includewhere the first anodized metal label and the second anodized metal labelare anodized metal substrates affixed to a surface of the core.

Example 21 can include subject matter such as a method of labeling animplantable medical device. The method comprises coupling a firstbiocompatible metal substrate and a second biocompatible metal substrateto a core of a header of the implantable medical device, the core havinga first bore and a second bore, wherein the first biocompatible metalsubstrate is positioned adjacent to the first bore and the secondbiocompatible metal substrate is positioned adjacent to the second bore,anodizing the first biocompatible metal substrate to include at least afirst color, anodizing the second biocompatible metal substrate toinclude at least a second color, the second color different from thefirst color, and overmolding the core including the first biocompatiblemetal substrate label and the second biocompatible metal substrate.

Example 22 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-21, to optionally includewhere anodizing the first biocompatible metal substrate and anodizingthe second biocompatible metal substrate are done prior to affixing thefirst biocompatible metal substrate and the second biocompatible metalsubstrate to the core. Example 23 can include, or can optionally becombined with the subject matter of one or any combination of Examples1-22, to optionally include anodizing the first biocompatible metalsubstrate and anodizing the second biocompatible metal substrate aredone using at least one of electrochemical anodizing and LASERanodizing.

Example 23 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-22, to optionally includecoupling a first lead of a lead assembly to the first bore, and couplinga second lead of a lead assembly to the second bore.

Example 24 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-23, to optionally includeanodizing a first annular ring to include the first color, anodizing asecond annular ring to include the second color, coupling the firstannular ring to a proximal end of the first lead, and coupling thesecond annular ring to a proximal end of the second lead.

Example 25 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-24, to optionally includeforming the core to include a first receiving cavity and a secondreceiving cavity, the first receiving cavity configured to receive thefirst biocompatible metal substrate and the second receiving cavityconfigured to receive the second biocompatible metal substrate.

Example 26 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-25, to optionally includeanodizing a first contact wire extending from a housing includingelectronic circuitry to include the first color, anodizing a secondcontact wire extending from the housing to include the second color,coupling the first contact wire to the a connector block positionedwithin the first bore, and coupling the second contact wire to aconnector block positioned within the second bore.

Example 27 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-26, to optionally includeanodizing the first biocompatible metal substrate to include a firsttext, and anodizing the second biocompatible metal substrate to includea second text, the second text different from the first text.

Example 28 can include, or can optionally be combined with the subjectmatter of one or any combination of Examples 1-27, to optionally includewhere anodizing the first biocompatible metal substrate to include thefirst color and anodizing the second biocompatible metal substrate toinclude the second color are done using a electrochemical anodizingprocess, and wherein anodizing the first biocompatible metal substrateto include the first text and anodizing the second biocompatible metalsubstrate to include the second text are done using a LASER anodizingprocess.

A method of labeling an implantable medical device, the methodcomprising:

Example 29 can include subject matter such as a method of labeling animplantable medical device. The method can include coupling abiocompatible metal substrate to a core of a header of the implantablemedical device, the core having a first bore and a second bore,anodizing a first portion of the biocompatible metal substrate toinclude a first color, anodizing a second portion of the biocompatiblemetal substrate to include a second color, the second color differentfrom the first color, wherein the first portion of the biocompatiblemetal substrate is positioned adjacent to the first bore and the secondportion of the biocompatible metal substrate is positioned adjacent tothe second bore, and overmolding the core including the firstbiocompatible metal substrate label and the second biocompatible metalsubstrate.

Each of these non-limiting examples can stand on its own, or can becombined in various permutations or combinations with one or more of theother examples.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention can be practiced. These embodiments are also referred toherein as “examples.” Such examples can include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to complywith 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims. Also, in the above Detailed Description,various features may be grouped together to streamline the disclosure.This should not be interpreted as intending that an unclaimed disclosedfeature is essential to any claim. Rather, inventive subject matter maylie in less than all features of a particular disclosed embodiment.Thus, the following claims are hereby incorporated into the DetailedDescription as examples or embodiments, with each claim standing on itsown as a separate embodiment, and it is contemplated that suchembodiments can be combined with each other in various combinations orpermutations. The scope of the invention should be determined withreference to the appended claims, along with the full scope ofequivalents to which such claims are entitled.

What is claimed is:
 1. An implantable medical device, comprising: a housing including electronic circuitry; a header coupled to the housing and including a core having a first face, a second face opposite the first face, a first side wall, and a second side wall opposite the first side wall, the core including: a first bore extending from the first side wall toward the second side wall; a first connector block opening in communication with the first bore; a first connector block positioned within the first connector block opening, wherein the first connector block includes a first identifier; and a first contact wire extending from the housing, the first contact wire including the first identifier and configured to couple to the first connector block.
 2. The implantable medical device of claim 1, wherein the core further includes: a first receiving cavity extending from the first side wall toward the second side wall, the first receiving cavity positioned adjacent to the first bore; and a first window extending from the first face to the receiving cavity such that the first window is in communication with the receiving cavity.
 3. The implantable medical device of claim 2, further including: a first metal label positioned within the first receiving cavity adjacent to the first bore, wherein the first metal label includes the first identifier.
 4. The implantable medical device of claim 3, wherein the first identifier is a color.
 5. The implantable medical device of claim 3, wherein the core further includes: a second bore extending from the first side wall toward the second side wall; a second receiving cavity extending form the first side wall toward the second side wall, the second receiving cavity positioned adjacent to the second bore; a second window extending from the first face to the receiving cavity such that the second window is in communication with the second receiving cavity; and a second connector block opening in communication with the second bore.
 6. The implantable medical device of claim 5, further including: a second metal label positioned within the second receiving cavity adjacent to the second bore, wherein the second metal label includes a second identifier; a second connector block positioned within the second connector block opening, wherein the second connector block includes the second identifier, the second identifier different from the first identifier; and a second contact wire extending from the housing, the second contact wire including the second identifier and configured to couple to the second connector block.
 7. The implantable medical device of claim 6, further including: a lead assembly including a first lead and a second lead, wherein the first lead includes a first metal label including the first identifier and is configured to be electrically coupled to the electronic circuitry via the first connector block and the first contact wire, and the second lead includes a second metal label including the second identifier and is configured to be electrically coupled to the electronic circuitry via the second connector block and the second contact wire.
 8. The implantable medical device of claim 6, wherein the first metal label and the second metal label are chosen from at least one of titanium, tantalum, tungsten, and stainless steel.
 9. The implantable medical device of claim 1, wherein the core is overmolded with a dielectric material.
 10. The implantable medical device of claim 1, wherein the first receiving cavity has a first area that is greater than a second area of the first window.
 11. An implantable medical device, comprising: a housing including electronic circuitry; a header coupled to the housing and including a core, the core including: a bore; and a connector block opening in communication with the first bore; a connector block positioned within the connector block opening and including a first identifier; and a contact wire extending from the housing, the contact wire including the first identifier and configured to couple to the connector block.
 12. The implantable medical device of claim 11, wherein the first identifier is a color.
 13. The implantable medical device of claim 11, further including: a receiving cavity positioned adjacent to the bore; a window in communication with the receiving cavity; and a metal label positioned within the first receiving cavity and including the first identifier.
 14. The implantable medical device of claim 13, wherein the first identifier on the metal label is visible through the window.
 15. The implantable medical device of claim 14, wherein the metal label is a first metal label, the device further including: a lead including a second metal label including the first identifier, wherein the lead is configured to be electrically coupled to the electronic circuitry via the connector block and the contact wire.
 16. A method of labeling an implantable medical device, the method comprising: positioning a connector block including at least a first color within a connector block opening of a core of a header, wherein the connector block opening is in communication with a bore of the core; coupling a contact wire extending from a housing to the connector block positioned within the bore, wherein the contact wire includes the first color; and overmolding the core including the biocompatible metal substrate label and the connector block.
 17. The method of claim 16, further including: coupling a biocompatible metal substrate to the core, wherein the biocompatible metal substrate is positioned adjacent to the bore and includes the first color.
 18. The method of claim 17, further including: anodizing the biocompatible metal substrate, the contact wire, and the connector block to include at least the first color.
 19. The method of claim 16, further including: coupling a lead to the bore, wherein the lead includes an annular ring having the first color.
 20. The method of claim 19, wherein the lead is positioned within the bore and is electrically coupled to the electronic circuitry via first connector block and the contact wire. 